Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
Recruiting · NCT06774079 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →Interventions studied
Mediterranean dietTirzepatide
What this trial is about
The purpose of this study is to use diet and an injectable medication called tirzepatide (Zepbound) glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GIP-GLP-1 RA) medication as adjunctive therapy (another treatment used together with the primary treatment) for Crohn's disease patients with mild disease who are on stable doses of biologic medication (infliximab or adalimumab) and who have a body mass index (BMI) of at least 27.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Adult patients (≥18 years old)
- Confirmed diagnosis of Crohn's disease
- Mildly active disease, defined by clinical symptoms using the Harvey Bradshaw Index (HBI) score between 5 and 7 (the HBI is a continuous score ranging from 0-16 where \<4 is considered remission)
- BMI ≥ 27 kg/m2
- Patients will be on stable doses of medical therapy (anti-tumor necrosis factor (TNF) alpha blockers)
Exclusion criteria
- Patients under 18 years of age
- Patients with ulcerative colitis
- Patients with infectious colitis
- BMI\<27 kg/m2
- Patients with type 1 or type 2 diabetes
- Contraindications to a GIP/GLP-1 RA, including patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2
- Patients already on GIP/GLP-1 RA therapy
- Patients with the following chronic symptoms: severe constipation, nausea, and/or vomiting
- Patients with the following medical history: small bowel obstruction in the last year, intestinal stricture, known or suspected diagnosis of gastroparesis
- Adults unable to consent
- Pregnant patients (will be confirmed via a pregnancy test)
- Prisoners
Where it is running
1 location listed across 1 US state.
- University of Miami - Miami, Florida, United States